Encare by Blairex Laboratories, Inc.

Encare by

Drug Labeling and Warnings

Encare by is a Otc medication manufactured, distributed, or labeled by Blairex Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ENCARE- nonoxynol-9 insert 
Blairex Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active ingredient (in each insert)

Nonoxynol-9 100 mg.

Purpose

Vaginal Contraceptive

Use

for the prevention of pregnancy.

Warnings

  • For vaginal use only
  • Not for rectal (anal) use

Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner.

Do not use if you or your sex partner has HIV/AIDS. If you do not know if you or your sex partner is infected, choose another form of birth control.

When using this product

  • you may get vaginal irritation (burning, itching, or a rash)

Stop use and ask a doctor if

  • you or your partner get burning, itching, a rash or other irritation of the vagina or penis

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • at least 10 minutes prior to intercourse: remove the protective wrap and insert Encare into the vagina (see diagram on package insert). Each Encare insert gives you one full hour of protection.
  • may be used with: condom or diaphragm for added protection.
  • before use: read all directions and special warnings on this package and the insert inside.

Other information

  • when used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate, the risk of catching or spreading HIV, the virus that causes AIDS
  • store at 15-30°C (59-86°F)
  • keep away from excessive heat and moisture.

Inactive ingredients

polyethylene glycols, sodium bicarbonate, sodium citrate, tartaric acid.

Manufactured for: Blairex Laboratories, Inc. P.O. Box 2127 Columbus, IN 47202 USA

Telephone
Questions or comments? Call TOLL FREE 1-800-252-4739
www.encare.net

Principal Display Panel - Carton Label

NDC: 50486-221-18

with Nonoxynol-9

The Spermicide Doctors Recommend Most

Encare®

Vaginal contraceptive inserts
for prevention of pregnancy

No Hormonal Side Effects

  • Easy To Use
  • Individually Wrapped
  • Convenient To Carry

18 INSERTS

Principal Display Panel - Carton Label

Principal Display Panel - Carton Label

NDC: 50486-221-12

with Nonoxynol-9

The Spermicide Doctors Recommend Most

Encare®

Vaginal contraceptive inserts
for prevention of pregnancy

No Hormonal Side Effects

  • Easy To Use
  • Individually Wrapped
  • Convenient To Carry

12 INSERTS

Principal Display Panel - Carton Label

Principal Display Panel - Carton Label

Birth Control
Women Trust

NDC: 50486-221-13

with Nonoxynol-9 The Spermicide
Doctors Recommend Most

Encare®

Vaginal contraceptive
inserts for the
prevention of pregnancy

No
Hormonal
Side
Effects

  • Easy To Use
  • Individually Wrapped
  • Convenient To Carry

12 INSERTS

Principal Display Panel - Carton Label
ENCARE 
nonoxynol-9 insert
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50486-221
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
nonoxynol-9 (UNII: 48Q180SH9T) (nonoxynol-9 - UNII:48Q180SH9T) nonoxynol-9100 mg
Inactive Ingredients
Ingredient NameStrength
polyethylene glycol 1000 (UNII: U076Q6Q621)  
polyethylene glycol 1450 (UNII: OJ4Z5Z32L4)  
tartaric acid (UNII: W4888I119H)  
sodium citrate (UNII: 1Q73Q2JULR)  
sodium bicarbonate (UNII: 8MDF5V39QO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50486-221-183 in 1 CARTON09/01/199901/01/2020
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 50486-221-122 in 1 CARTON09/01/199901/01/2020
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 50486-221-132 in 1 CARTON09/01/199901/01/2020
36 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/199901/01/2020
Labeler - Blairex Laboratories, Inc. (092575133)

Revised: 9/2013
 
Blairex Laboratories, Inc.